title: The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole.
abstract: BACKGROUND
  The treatment of bipolar disorder (BD) remains a challenge due to the complexity of the disease. Current guidelines represent an effort to assist clinicians in routine practice but have several limitations, particularly concerning long-term treatment. The ARIQUELI (efficacy and tolerability of the combination of lithium or aripiprazole in young bipolar non or partial responders to quetiapine monotherapy) study aims to evaluate two different augmentation strategies for quetiapine nonresponders or partial responders in acute and maintenance phases of BD treatment.
  
  
  METHODS
  The ARIQUELI study is a single-site, parallel-group, randomized, outcome assessor-blinded trial. BD I patients according to the DSM-IV-TR, in depressive, manic/hypomanic or mixed episode, aged 18 to 40 years, are eligible. After diagnostic assessments, patients initiated treatment in phase I with quetiapine. Nonresponders or partial responders after 8 weeks are allocated into one of two groups, potentiated with either lithium (0.5 to 0.8 mEq/l) or aripiprazole (10 or 15 mg). Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Outcome assessors are blinded to the treatment. The primary outcome is the evaluation of changes in mean scores on the CGI-BP-M between baseline and the endpoint at the end of each study phase.
  
  
  CONCLUSIONS
  The ARIQUELI study is currently in progress, with patients undergoing acute treatment (phase I), potentiation (phase II) and maintenance (phase III). The study will be extended until January 2015. Trials comparing lithium and aripiprazole with potentiate treatment in young BD I nonresponders to quetiapine in monotherapy can provide relevant information on the safety of these drugs in clinical practice. Long-term treatment is an issue of great importance and should be evaluated further through more in-depth studies given that BD is a chronic disease.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01710163.
authors.forename: Giovani
authors.initials: G
authors.lastname: Missio
authors.forename: Doris Hupfeld
authors.initials: DH
authors.lastname: Moreno
authors.forename: Fernando
authors.initials: F
authors.lastname: Fernandes
authors.forename: Danielle Soares
authors.initials: DS
authors.lastname: Bio
authors.forename: Márcio Gehardt
authors.initials: MG
authors.lastname: Soeiro-de-Souza
authors.forename: Domingos
authors.initials: D
authors.lastname: Rodrigues dos Santos
authors.forename: Denise Petresco
authors.initials: DP
authors.lastname: David
authors.forename: Luis Felipe
authors.initials: LF
authors.lastname: Costa
authors.forename: Frederico Navas
authors.initials: FN
authors.lastname: Demétrio
authors.forename: Ricardo Alberto
authors.initials: RA
authors.lastname: Moreno
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D001938:Brazil; D002985:Clinical Protocols; D003987:Dibenzothiazepines / Q000627:therapeutic use*; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D018020:Lithium Compounds / Q000627:therapeutic use*; D008297:Male; D010879:Piperazines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D000069348:Quetiapine Fumarate; D015363:Quinolones / Q000627:therapeutic use*; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D018020:Lithium Compounds; D010879:Piperazines; D015363:Quinolones; D000069348:Quetiapine Fumarate; D000068180:Aripiprazole